non-small-cell lung carcinoma (NSCLC)
Conditions
Interventions
Take one tablet of Tarceva or placebo oraaly every day.
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patients, >//
Exclusion criteria
Exclusion criteria: - Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab) - Patients whose tumours harbour EGFR activating mutation - Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy) - Use of pemetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in) - Patients who have undergone complete tumour resection after responding to platinum-based chemotherapy during the screening phase - Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or organ confined prostate cancer - CNS metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for >/=2 months - HIV, hepatitis B or hepatitis C infection - Any inflammatory changes of the surface of the eye (for complete exclusion criteria see protocol p35-36)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASSESSMENTS OF: - EFFICACY (Primary) Overall Survival - EFFICACY (Secondary) Progression Free Survival (RECIST) and Response (RECIST) - SAFETY Safety of the treatment will be evaluated by: adverse events, laboratory tests, vital signs, electrocardiogram and performance status. All subjects who received at least one dose of treatment will be included in the safety evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - MOLECULAR MARKER ANALYSIS: EGFR mutational analysis. Exploratory analyses of both tumour tissue and blood for other biomarkers relevant to EGFR signal transduction and erlotinib clinical benefit (such as, but not limited to, markers of Epithelial-Mesenchymal Transition (EMT)). - OPTIONAL BIOMARKER SAMPLE (non-DNA): Roche Clinical Repository (RCR) non-DNA specimen(s) will be taken from consenting subjects as described in the Schedule of Assessment tableThe RCR sampling is optionalRCR samples will be collected to promote, facilitate and improve individualized healthcare by better understanding/predicting erlotinib efficacy, dose responses, safety, mode of action, progression of NSCLC and associated diseases. These specimen(s) may be stored for up to 15 years after the end of study BO25460. - OPTIONAL BIOMARKERS SAMPLES (DNA): All subjects who have been enrolled in the study will be asked to donate an optional DNA specimen for pharmacogenetic and genetic research. RCR DNA sampling will involve taking a blood sample at baseline. The study protocol BO25460 which includes RCR sampling is submitted to the concerned Ethic Committee and is available for Competent Authority review upon request. These specimen(s) will be stored for up to 15 yearsafter the end of study BO25460. - MANDATORY BIOMARKER SAMPLES (MBS): A tumour sample will be provided within 3 weeks of the patient starting the scheduled noninvestigational) platinum-based chemotherapy. This sample will be used to assess the EGFR mutation status to confirm eligibility of the patient in the Blinded phase of the study. In addition, a mandatory plasma and serum sample will be taken. | — |
Countries
Netherlands
Outcome results
None listed